Sterilization of heat-sensitive silicone implant material by low-pressure gas plasma.

BACKGROUND: In recent years, plasma treatment of medical devices and implant materials has gained more and more acceptance. Inactivation of microorganisms by exposure to ultraviolet (UV) radiation produced by plasma discharges and sterilization of medical implants and instruments is one possible application of this technique. The aim of this study was to evaluate the effectiveness of this sterilization technique on silicone implant material. METHODS: Bacillus atrophaeus spores (10(6) colony-forming units [CFUs]) were sprayed on the surfaces of 12 silicone implant material samples. Four plasma sets with different gas mixtures (argon [Ar], argon-oxygen [Ar:O(2)], argon-hydrogen [Ar:H(2)] and argon-nitrogen [Ar:N(2)]) were tested for their antimicrobial properties. Post-sterilization mechanical testing of the implant material was performed in order to evaluate possible plasma-induced structural damage. RESULTS: The inductively coupled low-pressure plasma technique can achieve fast and efficient sterilization of silicone implant material without adverse materials effects. All four gas mixtures led to a significant spore reduction, and no structural damage to the implant material could be observed.

[Surface modification of metal implant materials by low-pressure plasma treatment]. / Oberflächenmodifikation metallischer Implantatmaterialien durch Niederdruckplasmabehandlung / Surface modification of metal implant materials by low-pressure plasma treatment.

BACKGROUND: Plasma treatment leads to a significant change of surface free energy of medical implant materials. These changes strongly influence protein and cell adhesion on the material surface. The aim of the study was to quantify the plasma-induced surface changes and to analyse whether the change of treatment parameters, such as pressure, gas mixture, energy and treatment time, influences the surface free energy of the implant materials. To improve the biocompatibility of the surfaces, polyamino acid coating experiments were performed. MATERIALS AND METHODS: Three different metal implant materials (X2CrNiMo18-15-3, Ti6Al4V, Ti6Al7Nb) were treated with a double-inductively coupled low-pressure plasma. The influence of treatment parameter variation on the surface free energy was evaluated by drop shape analysis. The plasma treated and non-treated materials were incubated in collagen I solution. Afterwards, the coatings were analysed by electron microscopy in terms of structure and adhesion. RESULTS: Drop shape analysis revealed that plasma treatment leads to a significant increase of surface free energy in all groups. Long plasma treatment times and low treatment pressures lead to a significant (p<0.05) extension of the detectable surface free energy increase. Coating experiments showed that only on plasma-treated samples solid and adherent collagen layers could be achieved.

Low-pressure microwave plasma sterilization of polyethylene terephthalate bottles.

A low-pressure microwave plasma reactor was developed for sterilization of polyethylene terephthalate (PET) bottles. In contrast to the established method using aseptic filling machines based on toxic sterilants, here a microwave plasma is ignited inside a bottle by using a gas mixture of nitrogen, oxygen, and hydrogen. To that effect, a reactor setup was developed based on a Plasmaline antenna allowing for plasma ignition inside three-dimensional packages. A treatment time below 5 s is provided for a reduction of 10(5) and 10(4) CFU of Bacillus atrophaeus and Aspergillus niger, respectively, verified by means of a count reduction test. The sterilization results obtained by means of this challenge test are in accordance with requirements for aseptic packaging machines as defined by the U.S. Food and Drug Administration and the German Engineering Federation. The plasma sterilization process developed here for aseptic filling of beverages is a dry process that avoids residues and the use of maximum allowable concentrations of established sterilants, e.g., hydrogen peroxide.

[A double inductively coupled low-pressure plasma for sterilization of medical implant materials]. / Doppelt induktiv gekoppeltes Niederdruckplasma zur Sterilisation von medizinischen Implantatmaterialien.

The potential of plasma treatment in medicine is only slowly gaining acceptance. Inactivation of germs through exposure to UV radiation produced by plasma discharges and sterilization of medical implant devices and instruments is one possible application of this technique. In addition, due to the manifold possibilities of coating through plasma processes, quick sterilization-coating combinations of medical implant devices are possible. To analyze the effectiveness of this sterilization process on different material surfaces, three different alloys (X2CrNiMo18-15-3, Ti6Al7Nb and Ti6Al4V) and one thermoplastic material (ultra-high molecular weight polyethylene, UHMWPE), commonly used in medical implant devices, were examined in the presented study. After spraying Bacillus atrophaeus spores (10(6) CFU) on the surfaces of four different implant materials tested in this study (X2CrNiMo18-15-3, UHMWPE, Ti6Al7Nb and Ti6Al4V), it was demonstrated in each of four gas mixtures used (Ar, Ar:O2, Ar:H2 and Ar:N2) that due to the application of inductively coupled low-pressure plasma technique, plain medical implant materials can be sterilized rapidly, and can be protective and efficient.

Plasma mediated collagen-I-coating of metal implant materials to improve biocompatibility.

This study describes the collagen-I coating of titanium and steel implants via cold low-pressure gas plasma treatment. To analyze the coatings in terms of biocompatibility osteoblast-like osteosarcoma cells and human leukocytes were cultivated on the metal surfaces. Two different implant materials were assessed (Ti6Al4V, X2CrNiMo18) and four different surface properties were evaluated: (a) plasma pretreated and collagen-I coated implant materials; (b) collagen-I dip-coated without plasma pretreatment; (c) plasma treated but not collagen-I coated; (d) standard implant materials served as control. The different coating characteristics were analyzed by scanning electron microscopy (SEM). For adhesion and viability tests calcein-AM staining of the cells and Alamar blue assays were performed. The quantitative analysis was conducted by computer assisted microfluorophotography and spectrometer measurements. SEM analysis revealed that stable collagen-I coatings could not be achieved on the dip-coated steel and titanium alloys. Only due to pretreatment with low-pressure gas plasma a robust deposition of collagen I on the surface could be achieved. The cell viability and cell attachment rate on the plasma pretreated, collagen coated surfaces was significantly (p < 0.017) increased compared to the non coated surfaces. Gas plasma treatment is a feasible method for the deposition of proteins on metal implant materials resulting in an improved biocompatibility in vitro. (c) 2010 Wiley Periodicals, Inc. J Biomed Mater Res, 2010.